Senior QA IT Specialist, GxP & Compliance

Alexion Pharmaceuticals, Inc.

Dublin

Hybrid

EUR 70,000 - 110,000

Full time

8 days ago

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Job summary

AstraZeneca | Alexion role at Senior Specialist, QA IT provides independent QA oversight for GxP computerised systems across their lifecycle. Partners with process owners, IT, Digital, Data and external suppliers to ensure systems are fit for use, compliant, secure and auditable.

Role applies regulatory requirements and industry best practices to enable compliant delivery, operation and retirement of technology used in regulated activities. Date posted 05-Nov-2026. Closing 18-Nov-2026.

Qualifications

  • QA oversight for GxP computerised systems and digital solutions across their lifecycle.
  • Applies regulatory requirements, AstraZeneca standards and industry good practice to enable compliant delivery.
  • Ensures data integrity controls meet ALCOA++ principles and proper access controls.

Responsibilities

  • Acts as QA IT lead for an assigned portfolio of GxP systems, platforms, projects or business functions.
  • Reviews validation/assurance plans, requirements, testing strategies and release decisions.
  • Leads investigations of significant system failures, data-integrity concerns and compliance events.
  • Represents QA IT in governance forums and communicates risk and actions clearly to stakeholders.

Job description

AstraZeneca | Alexion role at Senior Specialist, QA IT provides independent QA oversight for GxP computerised systems across their lifecycle. Partners with process owners, IT, Digital, Data and external suppliers to ensure systems are fit for use, compliant, secure and auditable.

Role applies regulatory requirements and industry best practices to enable compliant delivery, operation and retirement of technology used in regulated activities. Date posted 05-Nov-2026. Closing 18-Nov-2026.

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